Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT07204405
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2025-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Haemorrhage From Severe Neck and Facial Injuries - Characteristics, Management and Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D019838', 'term': 'Neck Injuries'}, {'id': 'D005151', 'term': 'Facial Injuries'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-09-24', 'studyFirstSubmitQcDate': '2025-09-24', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death from bleeding', 'timeFrame': '30 days', 'description': 'Death from bleeding within 30 days.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Facial injury', 'Neck injury', 'Trauma', 'Bleeding'], 'conditions': ['Trauma (Including Fractures)', 'Facial Bones Fracture', 'Neck Injuries']}, 'descriptionModule': {'briefSummary': 'This is a descriptive observational study of trauma patients admitted to the Trauma Unit at the Karolinska University Hospital Solna, Stockholm, Sweden. Data will be collected from the Karolinska Trauma Registry for all patients from 2015 to 2024. A more detailed dataset will be extracted from the Trauma Registry for all patients with serious facial or neck injuries. For those patients, data will also manually be extracted from their clinical records.', 'detailedDescription': 'Data will be collected from the Karolinska Trauma Registry for all patients from 2015 to 2024. A more detailed dataset will be extracted from the Trauma Registry for all patients with an Abbreviated Injury Scale (AIS) severity score of ≥ 3 for facial or neck injuries. Data will include demographics, injury mechanism, injury type, physiology, treatment and outcome. For those patients with a severe facial or neck injury, data will also manually be extracted from their clinical records regarding prehospital details, initial physiology, injury type, treatment and bleeding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients included in the Karolinska Trauma Registry. Those with an AIS\\>2 for neck or facial injury will be studied in more detail.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients included in the Karolinska Trauma Registry\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07204405', 'briefTitle': 'Haemorrhage From Severe Neck and Facial Injuries - Characteristics, Management and Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Haemorrhage From Severe Neck and Facial Injuries - Characteristics, Management and Outcomes', 'orgStudyIdInfo': {'id': 'K 2025-7172'}}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Magnus Hedberg', 'investigatorAffiliation': 'Karolinska Institutet'}}}}